(19 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on physiological data recording and analysis without mentioning any AI/ML capabilities.
No.
The device is described as a diagnostic tool used for recording physiological data and identifying vascular pathology, not for providing treatment or therapy.
Yes
The device is described as being used for "identification of vascular pathology" and "early detection of peripheral vascular disease," which are diagnostic purposes.
No
The device description explicitly states it is a "non invasive cardiovascular blood flow monitor" and is "supplied non-sterile with pressure cuffs," indicating it includes hardware components beyond just software. It also requires a Personal Computer with specific hardware requirements.
Based on the provided information, the BioMedix PADnet Lab is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the BioMedix PADnet Lab clearly states it is a "non invasive device" that records "physiological data from the lower extremity arterial system" using "pulse volume recordings and oscillometric segmental systolic blood pressures." This involves directly measuring physiological parameters from the patient's body, not analyzing samples taken from the body (like blood, urine, tissue, etc.).
- The intended use is for identifying vascular pathology based on these physiological measurements. This is a direct assessment of the patient's physical state, not an analysis of a biological sample.
Therefore, the BioMedix PADnet Lab falls under the category of a non-invasive diagnostic device used for physiological measurements, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioMedix PADnet Lab is a non invasive device used to record physiological data from the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures for use by the Physician in the identification of vascular pathology. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.
Product codes
JOM
Device Description
The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use in the early detection of peripheral vascular disease. The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements:
- . Windows 2000 Operating System or higher
- 128 MB RAM .
- 20 GB Free Hard Disk Space t
- 600 MHz Processor or higher .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremity arterial system
Indicated Patient Age Range
Adults
Intended User / Care Setting
healthcare professionals in a hospital or clinic environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).
0
K042616
page 1 of 5
OCT 1 2 2004
510(K) Summary of Safety and Effectiveness
General Information
| Submitter's Name: | BioMedix, Inc. |
|---|---|
| Address: | 4205 White Bear Parkway |
| St. Paul, MN 55110 | |
| Telephone: | 651-762-4010 |
| Contact Person: | Will Rogers or Dick Magnuson |
| Date Prepared: | July 23, 2004 |
| Registration Number: | 2134492 |
Device
| Name: | PADnet Lab |
|---|---|
| Trade Name: | PADnet Lab |
| Common Name: | Plethysmograph |
| Classification Name: | Blood Flow Monitor |
| Product Code: | JOM |
| Class: | II |
| Regulation Number: | 870.2780 |
1
K042614
page 2 of 5
Identification of Legally Marketed Devices
Name: Flostat Vascular Lab
K Number: K973644
Date Cleared: December 23, 1997
Description of the Device
The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use in the early detection of peripheral vascular disease. The PADnet Lab has been tested to the following standards.
- EN60601-1 Electrical Safety .
- EN60601-1-2 EMC .
- . ISO 10993-1 Biological evaluation
The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use by trained medical professionals in a hospital or clinic. It is not to be operated in an explosive atmosphere nor in the proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the PADnet Lab.
The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements:
- . Windows 2000 Operating System or higher
- 128 MB RAM .
- 20 GB Free Hard Disk Space t
- 600 MHz Processor or higher .
2
Intended Use Statement
The BioMedix PADnet Lab is a non invasive device used to gauge the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures to assist in the identification of vascular disease. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.
Components/ Part Numbers
| Description | BioMedix Part Number |
|---|---|
| 1- USB cable | 100-1600 |
| 1- Cuff kit | 7200 |
| BioMedix PADnet Lab | |
| Software Program CD ROM | 400-210 |
| 1-AC Power Cord | 350-215 |
| 1- PADnet Lab Operators Manual | 10650 |
Table of Comparisons
The following summary table of comparisons compares the new device (PADnet Lab) to the predicate device: Flowstat Vascular Lab.
| # | Area | New Device: PADnet Lab | Predicate Device: Flowstat
Vascular Lab | Same | Different |
|----|-----------------------------------|--------------------------|--------------------------------------------|------|-----------|
| 1 | Pulse Volume
Recording | Plethysmograph | Plethysmograph | X | |
| 2 | Segmental Pressure
flow sensor | Oscillometric | Distal Flow Sensor | | X |
| 3 | Patient Population | Male/Female Adult | Male/Female Adult | X | |
| 4 | Environment | Hospital or Clinic | Hospital or Clinic | X | |
| 5 | Power Source | AC converted to DC | AC converted to DC | X | |
| 6 | Weight | 4 lbs. | 26 lbs. | | X |
| 7 | Data acquisition | Single site | Bilateral | | X |
| 8 | Software Controls | Operator initiated | Operator initiated | X | |
| 9 | Size | 12 1/2"W X 10" D X 3 " H | 20 1/2" W X 17 3/4 " D X 7" H | | X |
| 10 | Cuff Deflation Rate | 3-5 mm Hg/Sec | 3-5 mm Hg/Sec | X | |
3
K042616
page 4 of 5
| 11 | Operating Environment | 0 to +40°C 15 - 90% | 0 to +40°C 15 - 90% | X |
|---|---|---|---|---|
| 12 | Storage Environment | -40 to +50° C 5-95% | -40 to +50° C 5-95% | X |
| 3 | Safety Standards | Yes | Yes | X |
| 14 | EMC | Yes | Yes | X |
| 15 | Prescription Device | Yes | Yes | X |
| 16 | Cuff Bladder Deflation | Automatic | Automatic | X |
| 17 | Inflation Method | Automatic | Automatic | X |
| 18 | Cuff Sizes | Multiple | Multiple | X |
| 19 | Clinical Reports | Yes | Yes | X |
| 20 | Printed Reports | Yes | Yes | X |
| 21 | Supplied Non-Sterile | Yes | Yes | X |
Discussion of Similarities and Differences
The PADnet Lab and the Flowstat Lab have the following similarities:
- Pulse Volume Recording .
- Patient Population ●
- Environment .
- Power Source ●
- Software Controls .
- Cuff Deflation Rate .
- Operating Environment .
- Storage Environment .
- Safety Standards .
- . EMC
- . Prescription Device
- Cuff Bladder Deflation ●
- Inflation Method .
- Cuff Sizes .
- . Clinical Reports
- . Printed Reports
- Supplied Non-Sterile .
The differences, with comments, are the following:
- Segmental Pressure flow sensor The PADnet Lab uses Oscillometric not distal . flow sensor.
- Weight PADnet Lab is significantly less. ●
- Data acquisition -- PADnet Lab is single site not bilateral. .
- . Size - PADnet Lab is significantly smaller.
4
Thus, even though the PADnet Lab is not identical to the Flowstat Vascular Lab, we at BioMedix believe it should be granted substantial equivalence because:
- It has the same intended use as the predicate device. .
- It has the same technical characteristics as the predicate device and does not raise . any new types of safety or effectiveness concerns.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird in flight, composed of three curved lines. The text is arranged around the top and left side of the circle.
OCT 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomedix, Inc. c/o Ms. Laura Danielson 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891
Re: K042616
Trade Name: Biomedix PADnet Lab Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, pneumatic, or photoelectric plethysmographs Regulatory Class: Class II (two) Product Code: JOM Dated: September 22, 2004 Received: September 23, 2004
Dear Ms. Danielson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for woo bayed in to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou mayy are servisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or dayses to the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
Page 2 -- Ms. Laura Danielson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimma for
Drém D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Biomedix PADnet Lab
Indications for Use:
Callohis for Use.
The BioMedix PADnet Lab is a non invasive device used to record physiological data The DioModix PADmit Larterial system using pulse volume recordings and from the 10wer extremity artitis blood pressures for use by the Physician in the osentification of vascular pathology. It is intended to be used by healthcare identification of vasedial paintees.
professionals in a hospital or clinic environment. The device is not intended for professionals in a nebblished for use on or intended for use on or near non intact skin.
User Profile: Patient Population: Male/Female, Adults Environment of Use: Hospitals or Clinics
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺗﮭﺎ ﮐﮧ ﻧﮩﯿﮟ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐ immimle
(Division Sign-Off) Division of Cardiovascylar Devices Division omber KO40616
Page of ______________________________________________________________________________________________________________________________________________________________________
(Posted November 13, 2003)